Abstract
Advanced Therapeutic Medicinal Products (ATMP) are a heterogenous group of investigational medicinal products at the forefront of innovative therapies with direct applicability in respiratory diseases. ATMPs include, but are not limited to, stem cells, their secretome, or extracellular vesicles, and each have shown some potential when delivered topically within the lung. This review focuses on that subset of ATMPs. One key mode of delivery that has enabling potential in ATMP validation is aerosol-mediated delivery. The selection of the most appropriate aerosol generator technology is influenced by several key factors, including formulation, patient type, patient intervention, and healthcare economics. The aerosol-mediated delivery of ATMPs has shown promise for the treatment of both chronic and acute respiratory disease in pre-clinical and clinical trials; however, in order for these ATMP device combinations to translate from the bench through to commercialization, they must meet the requirements set out by the various global regulatory bodies. In this review, we detail the potential for ATMP utility in the lungs and propose the nebulization of ATMPs as a viable route of administration in certain circumstances. Further, we provide insight to the current regulatory guidance for nascent ATMP device combination product development within the EU and US.
Highlights
Advancements in science and technology have seen the development of new therapeutic opportunities for the treatment and prevention of high-burden human diseases with unmet medical needs [1]
The definition of each class is established in the relevant regulatory documents which define somatic cell therapy medicines as products which contain or are comprised of cells or tissues which have been modified for intended clinical use, or biological products which are transferred from one patient to donor with a different use [5]
The aerosol-mediated delivery of Advanced therapeutic medical products (ATMP) for the treatment of respiratory disease is under investigation in pre-clinical and clinical studies, and the results obtained from on-going clinical trials will have a significant impact on the future treatment of acute and chronic respiratory diseases
Summary
Advancements in science and technology have seen the development of new therapeutic opportunities for the treatment and prevention of high-burden human diseases with unmet medical needs [1]. ATMP is a broad term used to group three medicinal product classes intended for human use which encompass somatic cell therapy medicine, gene therapy medicines, and tissue-engineered medicines [3]. The definition of each class is established in the relevant regulatory documents which define somatic cell therapy medicines (sCTMPs) as products which contain or are comprised of cells or tissues which have been modified for intended clinical use, or biological products which are transferred from one patient to donor with a different use [5]. This review will focus solely on somatic cell therapy medicine and its utility in respiratory disease, and details the current regulatory hurdles that need to be addressed in bringing a ATMP device combination product to market
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